Results of a Phase II Trial of Cetuximab plus Capecitabine/Irinotecan as First-Line Therapy for Patients with Advanced and/or Metastatic Colorectal Cancer

Cartwright, Thomas H.; Kuefler, Paul R.; Cohn, Allen Lee; Hyman, William; Berger, Maury; Richards, Donald A.; Vukelja, Svetislava J.; Nugent, John; Ruxer, Robert L.; Boehm, Kristi A.; Asmar, Lina

doi:10.3816/ccc.2008.n.052

Cited by 16 publications

(11 citation statements)

References 10 publications

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“…Additionally, five phase II clinical trials reported incidence rates of grade 3-4 IRs from 1-5% in patients with mCRC treated with cetuximab alone or cetuximab in combination with chemotherapies [28,32-34,38]. …”

Section: Incidence Rates Of Irsmentioning

confidence: 99%

Systematic Review on Infusion Reactions Associated with Chemotherapies and Monoclonal Antibodies for Metastatic Colorectal Cancer

Song

Long²,

Barber³

et al. 2012

CCP

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Objective: The objective of this systematic review is to summarize the literature to date on the rates of infusion reactions (IR) associated with chemotherapies and monoclonal antibody (mAb) drug therapies used for the treatment of metastatic colorectal cancer (mCRC) and the associated clinical and economic impact. Methods: This study searched Medline, Medline (R) In-Process, Embase and Cochrane Library databases for studies on IRs associated with chemotherapy and mAbs in mCRC patients from 2000-2011.Results: For chemotherapy, the incidence of IRs ranged from 0-71% for all grades and 0-15% for grade 3-4. Rates of all grade IRs associated with cetuximab ranged from 7.6-33% and grade 3-4 IR rates were 0-22%. Rates of all grade IRs associated with panitumumab ranged from 0-4% and rates of grade 3-4 IRs ranged from 0-1%. The overall rate of IRs associated with bevacizumab ranged from 1.6-11%, with a rate of 0-4% for grade 3-4 IRs. A range of 50-100% of patients with grade 3-4 IRs terminated chemotherapy, and 34-100% of cetuximab patients with grade 3-4 IRs discontinued cetuximab therapy. No data were reported for bevacizumab or panitumumab. Only one study evaluated the economic impact of IRs. The study compared cetuximab administrations without an IR to those with an IR requiring resource utilization and found that mean costs were $9308 and $1725 higher for those with an IR requiring an emergency room visit or hospitalization and for those with an IR requiring outpatient treatment, respectively. Conclusions: The incidence of IRs varies among different mAbs; and IRs may cause treatment disruption and require costly medical interventions.

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Section: Incidence Rates Of Irsmentioning

confidence: 99%

Systematic Review on Infusion Reactions Associated with Chemotherapies and Monoclonal Antibodies for Metastatic Colorectal Cancer

Song

Long²,

Barber³

et al. 2012

CCP

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“…Heinemann et al have demonstrated an overall RR of 42%, with an overall disease control rate of 91% (Table 6) [43,44]. Cartwright et al [45] have demonstrated in 53 evaluable patients that 5.7% had complete responses, 37.7% had partial responses, and 43.4% had stable disease with median survival of 20.5 months, with 45.7% of patients remaining alive at the time of the report ( Table 6).…”

Section: Capecitabine In Combination With Oxaliplatin or Irinotecanmentioning

confidence: 99%

Capecitabine versus 5-fluorouracil in colorectal cancer: where are we now?

et al. 2011

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Fluorouracil (5-FU) remains the most widely used agent for colorectal cancer. Capecitabine is a rationally designed 5-FU pro-drug developed to mimic the continuous infusion of 5-FU while avoiding complications and inconvenience of intravenous administration. Capecitabine is absorbed intact from the gastrointestinal tract, converted enzymatically to active 5-FU, and released directly into the tumor. Capecitabine's efficacy and safety are shown in multiple phase III trials across different disease stages and therapy lines. Three randomized phase III trials demonstrated the equivalence of capecitabine plus oxaliplatin (XELOX) versus 5-FU/leucovorin (LV)/oxaliplatin (FOLFOX). The safety of capecitabine compared with 5-FU depends on the regimen of 5-FU used. The adverse event rate with oxaliplatin in combination with infusional 5-FU is similar to that of capecitabine plus oxaliplatin but is associated with more neutropenia and venous thrombotic events; capecitabine plus oxaliplatinbased regimens tend to be associated with more grade 3 diarrhea and hand-foot skin reaction. Combination therapy with capecitabine and irinotecan (CapeIRI) versus 5-FU/ LV and irinotecan (FOLFIRI) had more variable results; some former schedules resulted in excessive treatmentrelated toxicity. More recent data show that lower capecitabine and irinotecan doses, different schedules, and combination with targeted agents (e.g, bevacizumab) have resulted in more favorable outcomes.

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“…Common regimens evaluated include: FOLFOX4 [25], XELOX [26], XELIRI [27], and 5-FU plus folinic acid (the AIO regimen) [28]. This growing body of data makes cetuximab plus chemotherapy an option for those patients ineligible for bevacizumab-based therapy.…”

Section: Bevacizumabmentioning

confidence: 99%

The Evolving Role of Monoclonal Antibodies in Colorectal Cancer: Early Presumptions and Impact on Clinical Trial Development

Eng

2010

The Oncologist

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Targeted biologic agents have an established role in treating metastatic colorectal cancer (mCRC). Bevacizumab, a recombinant monoclonal antibody against the vascular endothelial growth factor ligand is approved by the U.S. Food and Drug Administration (FDA) for bevacizumab-naïve patients. Cetuximab, a chimeric monoclonal antibody (mAb) against the epidermal growth factor receptor (EGFR) is FDA approved as a single agent, or in combination with irinotecan, in both irinotecan-naïve and refractory patients, and has additional efficacy in combination with oxaliplatin. Panitumumab, a fully human EGFR mAb, is FDA approved as a single agent in refractory patients but has additional efficacy in combination with chemotherapy. After reaching a temporary therapeutic plateau of FDA-approved agents for the treatment of mCRC, pivotal results have developed that critically affect the care for these patients. Correlative data from randomized trials of EGFR inhibitors across disease settings have demonstrated higher response rates, specifically for patients with wild-type K-RAS tumors. The interpretation of the B-RAF mutation and other molecular markers may further define the appropriateness of anti-EGFR therapy. Recent literature revealed that the first-line use of combined anti-EGFR therapy plus bevacizumab resulted in inferior outcomes and additional toxicities. Furthermore, the role of biologic agents for locally advanced colon cancer cannot be advocated at this time. With impending changes in the health care system, the economic impact of mAbs will continue to be scrutinized. Hence, as the significance of molecular markers continues to develop, their role as it pertains to the appropriate use of biologic agents in the treatment of mCRC will continue to evolve. The Oncologist 2010;15:73-84

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Results of a Phase II Trial of Cetuximab plus Capecitabine/Irinotecan as First-Line Therapy for Patients with Advanced and/or Metastatic Colorectal Cancer

Cited by 16 publications

References 10 publications

Systematic Review on Infusion Reactions Associated with Chemotherapies and Monoclonal Antibodies for Metastatic Colorectal Cancer

Systematic Review on Infusion Reactions Associated with Chemotherapies and Monoclonal Antibodies for Metastatic Colorectal Cancer

Capecitabine versus 5-fluorouracil in colorectal cancer: where are we now?

The Evolving Role of Monoclonal Antibodies in Colorectal Cancer: Early Presumptions and Impact on Clinical Trial Development

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